Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment

Launched by BRISTOL-MYERS SQUIBB · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a drug called BMS-986278 to understand how it is processed in the body and to check its safety. The researchers are looking at two groups of people: those with different levels of liver problems (called hepatic impairment) and healthy individuals with normal liver function. The trial will include participants aged between 18 and 80 years who meet certain health criteria, such as having a specific weight and body mass index. People with mild, moderate, or severe liver impairment due to chronic liver disease or past alcohol use will be included, as well as healthy participants matched by age, weight, sex, and race/ethnicity.

If you or a family member joins this study, you can expect to undergo health evaluations to determine eligibility. Participants will be monitored closely to see how the medication affects them and to ensure their safety throughout the trial. It's important to note that individuals with a history of alcohol abuse or severe liver disease, among other health issues, will not be eligible to participate. This study aims to provide valuable information about how BMS-986278 can be safely used, particularly in people with liver conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• All Participants:
• • Must have a body mass index (BMI) between 18 and 40 kg/m\^2 (inclusive), and body weight ≥ 50 kg.
• Mild, Moderate, or Severe Hepatic Impairment Participants:
• • Mild, moderate, or severe hepatic impairment (HI) or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
• • Mild, moderate, and severe HI participants will be enrolled according to the Child-Pugh classification score.
• Matched Healthy Participants:
• • Free of any clinically significant disease that would interfere with the study evaluations.
• • Normal hepatic function participants will be enrolled and matched individually with HI participants with respect to age (± 10 years), weight (± 20%), sex, and race/ethnicity (Japanese and Chinese participants vs non-Japanese and non-Chinese participants).
• Exclusion Criteria:
• All Participants:
• • History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women, or 14 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
• • Must not have had any prior exposure to BMS-986278.
• Mild, Moderate, or Severe Hepatic Impairment Participants:
• • Acute liver disease (eg, caused by an acute infection or drug toxicity).
• • History of initial stage/planned liver transplantation within 6 months of screening or has received a liver transplant.
• Matched Healthy Participants:
• • Any significant medical condition, or psychiatric illness that would prevent participant from participating in the study.
• • Other protocol-defined inclusion/exclusion criteria apply.

Trial Officials